Anchor instrumentation and methods

ABSTRACT

Some embodiments of a medical device anchor system includes an anchor sleeve and a catheter (or other medical instrument) to advance though a working channel of the anchor sleeve. The anchor sleeve may have a subcutaneous cuff device arranged along an outer surface. In such circumstances, the embedded cuff device can inhibit the migration of infection from outside the skin and into the blood stream.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.12/793,261 filed on Jun. 3, 2010 by Michael S. Rosenberg, which is adivision of U.S. patent application Ser. No. 11/763,576 filed on Jun.15, 2007 by Michael S. Rosenberg, the contents of which are incorporatedherein by reference.

TECHNICAL FIELD

This document relates to anchor instrumentation, such as an anchordevice for use in placement of a catheter or other medical instrument.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Following introduction into thepatient, the catheter is typically secured to the patient using a tapepatch or by suturing an attached hub to the skin. Some catheters may bedelivered to a particular site in the body and remain in position for anextended period of time. For example, chronic dialysis patients may havea dialysis catheter arranged in a blood vessel for weeks or months at atime.

SUMMARY

Some embodiments of a medical device anchor system include an anchorsleeve and a catheter (or other medical instrument) to advance though aworking channel of the anchor sleeve. The anchor sleeve may have asubcutaneous cuff device arranged along an outer surface. Thesubcutaneous cuff device can receive ingrowth of bodily tissue over aperiod of time when disposed in the subcutaneous layer. In suchcircumstances, the embedded cuff device can inhibit the migration ofinfection from outside the skin, along the anchor system, and into theblood stream. Furthermore, in the embodiments in which the cuff deviceis arranged on the anchor sleeve (rather than on the catheter body), thecatheter can be distally advanced such that the cuff-to-tip distancefrom the subcutaneous cuff device to the catheter tip can be selectivelyadjusted. Thus, the cuff-to-tip distance can be customized by apractitioner while the catheter tip is inside the patient's bodydepending on the size of the patient, the anatomy of the patient, andother factors.

In some embodiments, an anchor sleeve device may include an elongatebody that defines at least one working channel extending from a proximalportion to a distal tip portion. The anchor sleeve device may alsoinclude a subcutaneous anchor mechanism coupled to the elongate body.The subcutaneous anchor mechanism may have one or more flexible anchorsthat extend away from the body wall when in a deployed orientation in asubcutaneous layer. The anchor sleeve device may further include asubcutaneous cuff device arranged along an outer surface of the elongatebody at a position distally of the one or more flexible anchors. Thesubcutaneous cuff device may comprise a biocompatible material toreceive ingrowth of bodily tissue when disposed in the subcutaneouslayer.

Particular embodiments may include an anchor system for placement of acatheter device. The anchor system may include an anchor sleeve havingan elongate body that defines at least one working channel extendingfrom a proximal portion to a distal tip portion of the anchor sleeve.The anchor sleeve may also have a subcutaneous cuff device arrangedalong an outer surface of the elongate body. The subcutaneous cuffdevice may comprise a biocompatible material to embed in bodily tissuewhen disposed in a subcutaneous layer. The anchor system may alsoinclude a catheter device to advance though the working channel of theanchor sleeve and into a targeted body site. The catheter device maydefine at least one lumen that extends to a catheter tip opening. Whenthe catheter device is advanced through the working channel of theanchor sleeve, a distance from the subcutaneous cuff device to thecatheter tip opening can be adjusted.

Some embodiments include a method of delivering a catheter device to aninternal body site. The method may include advancing an anchor sleevethrough a percutaneous opening so that a subcutaneous cuff devicearranged along an outer surface of the anchor sleeve is disposed in asubcutaneous region. The subcutaneous cuff device may comprise abiocompatible material that receives tissue ingrowth when disposed inthe subcutaneous region. The method may also include advancing acatheter device though a working channel of the anchor sleeve and towarda targeted body site. The catheter device may define at least one lumenthat extends to a catheter tip. The distance from the subcutaneous cuffdevice to the catheter tip may define a cuff-to-tip distance. The methodmay further include adjusting the cuff-to-tip distance by moving thecatheter device relative to the anchor sleeve while the subcutaneouscuff device is disposed in the subcutaneous region.

In certain embodiments, an anchor sleeve device includes an elongatebody that defines at least one working channel extending from a proximalopening to a distal tip opening so as to receive a catheter. The anchorsleeve device may also include a subcutaneous anchor mechanism coupledto the elongate body. The subcutaneous anchor mechanism may have one ormore flexible anchors that extend away from the body wall when in adeployed orientation in a subcutaneous layer. The anchor sleeve devicemay further include a locking device that releasably affixes to thecatheter when the catheter is received in the working channel. Theanchor sleeve device may also include an actuator that is adjustablerelative to the elongate body from a first position to a secondposition. The adjustment of the actuator may simultaneously shift theflexible anchors to the deployed orientation and shift the lockingdevice to compress at least a portion of an outer surface of thecatheter when the catheter is received in the working channel.

These and other embodiments may provide one or more of the followingadvantages. First, the subcutaneous cuff device arranged along an outersurface of the anchor sleeve can serve as a barrier to infection. Forexample, the subcutaneous cuff device can receive ingrowth of bodilytissue or otherwise embedded into the surrounding tissue over a periodof time, thereby inhibiting the migration of infection from outside theskin and into the blood stream.

Second, in some embodiments, a catheter or other medical instrument canbe distally advanced such that the cuff-to-tip distance from thesubcutaneous cuff device to the instrument tip can be selectivelyadjusted. Thus, the cuff-to-tip distance can be customized by apractitioner while the catheter tip is inside the patient's bodydepending on the size of the patient, the anatomy of the patient, andother factors.

Third, because the cuff-to-tip distance can be selectively adjusted bythe practitioner during use in a patient, there is a reduced need tomaintain an inventory of catheters having a fixed cuff-to-tip distance.For example, some catheters included a cuff device affixed on an outersurface of the catheter body, thereby providing a fixed andnonadjustable cuff-to-tip distance. Hospitals or clinics would maintaina vast inventory of these catheter-cuff devices so that a wide varietyof cuff-to-tip distances can be selected and used by the practitioners.In some embodiments described herein, the cuff device is arranged on ananchor sleeve that is movable relative to the catheter, therebyproviding an adjustable cuff-to-tip distance. As such, hospitals orclinics may no longer be required to maintain vast inventories ofcatheters having a range of fixed cuff-to-tip distances.

Fourth, some embodiments of the anchor sleeve may include subcutaneousanchors that retain the anchor sleeve in the subcutaneous region. Forexample, the anchors may comprise adjustable tines comprising a materialthat exhibits superelasticity when used in a human body (e.g., Nitinolor the like). The anchors can be deployed in the subcutaneous region soas to at least temporarily retain the anchor sleeve in engagement withthe patient's body while the cuff device embeds with the surroundingtissue over a period of time. Thereafter, the cuff device may functionas a long term anchor instrument in place of, or in addition to, thepreviously described tines.

Fifth, some embodiments of the anchor sleeve may include a lockingdevice that can be actuated to releasably secure the catheter (or othermedical instrument) to the sleeve body after the catheter has beenadvanced through the sleeve device toward a targeted location. In somecircumstances, the locking device can also form a seal around thecatheter when connected thereto. A single actuator can be adjusted tocontemporaneously shift the flexible anchors to a deployed orientationin the subcutaneous region and shift the locking device to act upon thecatheter.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an anchor sleeve device in accordancewith some embodiments.

FIG. 2 is a perspective view of the anchor sleeve device of FIG. 1 withthe anchors is a non-deployed position.

FIG. 3 is a side view of a portion of the anchor sleeve device of FIG.1.

FIG. 4 is a cross-sectional view of the anchor sleeve device of FIG. 3.

FIG. 5 is another cross-sectional view of the anchor sleeve device ofFIG. 3.

FIG. 6A is another cross-sectional view of the anchor sleeve device ofFIG. 3.

FIG. 6B is an exploded perspective view of an actuator of the anchorsleeve of FIG. 6A.

FIG. 7 is a side view of the anchor sleeve device of FIG. 1 beingadvanced into a subcutaneous region.

FIG. 8 is another side view of the anchor sleeve device of FIG. 7 havingthe anchors in a deployed position and having a catheter device passingtherethrough.

FIGS. 9-10 are top and side views of an anchor sleeve device havingnon-retractable anchors, in accordance with some embodiments.

FIG. 11 is a perspective view of an anchor sleeve device having noanchor tines, in accordance with some embodiments.

FIG. 12 is a perspective view of an anchor sleeve device having no cuffdevice, in accordance with some embodiments.

FIGS. 13-14 are perspective views of an anchor system used to advance acatheter device to a targeted site in a heart chamber.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some embodiments of a medical device anchor system include an anchorsleeve and a catheter (or other medical instrument) to advance though aworking channel of the anchor sleeve. As described in more detail below,the anchor sleeve may have a subcutaneous cuff device that embeds withthe surrounding bodily tissue when disposed in the subcutaneous layerover a period of time. In such circumstances, the embedded cuff devicecan inhibit the migration of infection from outside the skin, along theanchor system, and into the blood stream. Also as described in moredetail below, the catheter is movable relative to the anchor sleeve, sothe cuff-to-tip distance can be selectively adjusted by a practitionerwhile the catheter tip is inside the patient's body.

Referring to FIGS. 1-2, an anchor sleeve device 100 can be used in asystem for placement of a catheter or other medical instrument into thebody of a patient. The sleeve device 100 may include an elongate body110, into which a catheter or other medical instrument can be inserted.The sleeve device 100 includes a distal tip portion 120 that maypenetrate through a skin entry point and into the subcutaneous layeradjacent to the skin. Also, the sleeve device 100 includes a proximalportion 130 that can remain external to the skin so as to provide aninsertion path for a catheter or other medical instrument. As describedin more detail below, some embodiments of the sleeve device 100 mayinclude a cuff 140, a depth indicator 150, one or more subcutaneousanchors 160, an actuator 170, a stopper 180, or a combination thereof.

In some embodiments, the sleeve device 100 may be inserted through apercutaneous opening formed in the skin (e.g., a puncture, an incision,or the like) and into the subcutaneous region so that the cuff 140 restsin the subcutaneous region (refer, for example, to FIGS. 7-8). The cuff140 may be made of a biocompatible material (e.g., a polyester materialsuch as Dacron, a polytetraflouroethelene material such as a Goretexmesh, titanium mesh, or the like) that is configured to receive theingrowth of bodily tissue or otherwise embed with the surroundingtissue. As such, the cuff 140 may embed in the subcutaneous tissue overa period of time to limit or prevent the migration of infection fromoutside the skin to components or anatomical structures (e.g., bloodvessels) distal of the cuff 140. After initial insertion of the sleevedevice 100 into the subcutaneous region, the subcutaneous anchors 160may be deployed in the subcutaneous region to assist in retention of thesleeve device 100 in position, thereby permitting the cuff 140 tosufficiently embed over a period of time (refer, for example, to FIG.8).

In some embodiments, the sleeve device 100 may be used for long-termanchoring of a catheter or other medical instrument in a patient. Forexample, a chronic dialysis catheter may be advanced through the sleevedevice 100 and into a patient requiring ongoing dialysis treatments. Thedialysis catheter may reside in the patient's body for a long-termperiod of weeks or months. The cuff 140 may be designed to function as along-term anchor instrument and as a barrier for infection, which can beaccomplished through tissue ingrowth into the cuff 140. In thisembodiment, the cuff 140 comprises a Dacron material, which may includepolyester, and may have a porous texture to encourage tissue ingrowth.In alternative embodiments, the cuff 140 may comprise other materials(e.g., Goretex mesh, titanium mesh or the like) suitable for use in thesubcutaneous region to encourage tissue ingrowth. In additionalembodiments, a combination of biocompatible materials may be used in thecuff 140. Although the sleeve device 100 is shown as having a singlecuff 140 in this embodiment, it should be understood from thedescription herein that more than one cuff can be employed on an outersurface of the sleeve device 100.

In some embodiments, the depth indicator 150 is present on the body 110of the sleeve device 100 to assist the user in placing the sleeve device100 to a desired depth in a patient. As described below in connectionwith FIGS. 7-8, the sleeve device 100 can be inserted through an entrypoint in the skin into the subcutaneous layer until the depth indicator150 is adjacent to the epidermis at the skin entry point. In someembodiments, the depth indicator 150 can include one or moreindentations in the body 110. In additional embodiments, the depthindicator 150 could be one or more markings indicating the depth atwhich the sleeve device 100 has been inserted.

Still referring to FIGS. 1-2, the sleeve device 100 includes one or moresubcutaneous anchors 160 for use in the temporary anchoring of at leasta portion of body 110 in the subcutaneous layer under the skin. In someembodiments, the subcutaneous anchors 160 may comprise a material thatexhibits superelasticity when used in the patient's body. As such, thesubcutaneous anchors can flexibly shift from a non-deployed position toa deployed position when in the subcutaneous layer. For example, theanchors 60 may be formed from a length of nitinol wire or from a sheetof nitinol material, which has been processed to exhibit superelasticitybelow or at about a normal human body temperature, such as below or atabout 37 degrees C. The nitinol material may comprise, for example,Nickel Titanium (NiTi), Niobium Titanium (NbTi), or the like.Alternatively, the subcutaneous anchors 160 may comprise a metalmaterial such as stainless steel, spring steel, titanium, MP35N andother cobalt alloys, or the like. In these embodiments, the subcutaneousanchors 160 can be formed from a material or materials that allow themto be adjustable from a non-deployed position to a deployed position.

In some embodiments, the subcutaneous anchors 160 can be flexed to astressed condition when in the non-deployed position (e.g., prior toplacement of the sleeve device 100 in a patient). For example, as shownin FIG. 2, the subcutaneous anchors 160 may be retracted into the body110 when in the non-deployed position. When deployed, as shown in FIG.1, the subcutaneous anchors 160 can return to a shape (e.g., byexhibiting superelastic characteristics) that allows the subcutaneousanchors 160 to at least temporarily retain a portion or all of the body110 in the subcutaneous region for a period of time until tissue hasproperly adhered to the cuff 140. The subcutaneous anchors 160 may bedesigned with a curvature that facilitates the transition from thenon-deployed to the deployed position. Furthermore, the curvature of theanchors 160 may be configured to eliminate or reduce the potentialdamage done to the skin during deployment of the anchors 160. Forexample, the anchors 160 may include a convex curvature that abutsagainst the underside of the skin in a manner that prevents the tips ofthe anchors 160 from piercing through the skin.

In use, the subcutaneous anchors 160 can be shifted to the non-deployedposition (refer, for example, to FIG. 2) prior to insertion so as tominimize resistance and possible damage to the skin when insertedthrough the skin entry point. When the anchor sleeve device 100 has beeninserted to the intended depth inside the subcutaneous layer, theanchors 160 can be shifted to the deployed position (refer, for example,to FIG. 1) to provide at least temporary anchoring for some or all ofthe anchor sleeve device 100. When removal of the anchor sleeve device100 is desired, the subcutaneous anchors can be shifted to thenon-deployed position prior to removal to minimize resistance andpossible damage to the skin and subcutaneous region.

As shown in FIG. 2, the actuator 170 can be adjusted relative to thebody so as to cause the subcutaneous anchors 160 to retract to thenon-deployed position. In this embodiment, the actuator 170 can bedepressed until it contacts the stopper 180 causing the subcutaneousanchors 160 to retract into the body 110. Transitioning the subcutaneousanchors 160 from the deployed position (FIG. 1) to the non-deployedposition (FIG. 2) can allow for easier insertion of the anchor sleevedevice 100 into a subcutaneous region through the skin entry point.After the sleeve device 100 is inserted into the patient, the actuator170 can be shifted away from the stopper 180 to urge the subcutaneousanchors 160 to extend from the body 110 (as shown in FIG. 1). In someembodiments, the anchors 160 can then act as temporary anchor for thesleeve device 100 for a period of time to allow the surrounding tissueto properly adhere to the cuff 140.

Referring now to FIGS. 3-4, the body 110 of the sleeve device 100 mayhave an elongate shape and can comprise a biocompatible material, suchas PEEK (polyetheretherketone), polyethylene, polyimide, or the like.The body 110 may have a modified elliptical cross-sectioned shape (asshown, for example, in FIG. 4) and may include a taper along the distilportion 120 that facilitates insertion of the sleeve device 100 throughthe skin of a patient. In this embodiment, the previously described cuff140 is located on the body 110 adjacent to this taper (as shown in FIG.3). Alternatively, the cuff 140 may be located along the tapered regioncloser to the distal tip, or may be located in a more proximal positioncloser to the anchors 160. As shown in FIG. 3, the body 110 may alsoinclude anchor holes 112 through which the anchors 160 extend whendeployed.

Referring to FIG. 4, in some embodiments, the sleeve device 100 caninclude one or more internal channels 200 and 210. For example, thesleeve device 100 may include a working channel 200 to receive acatheter or other medical instrument, and may also include an actuatorchannel 210 to accommodate the actuation of the subcutaneous anchors160.

The working channel 200 can extend through the entire length of thesleeve device 100 from the distal tip portion 120 to the proximalportion 130. After insertion of at least a portion of the body 110 intoa subcutaneous region, the working channel 200 can be used to introducea catheter or other medical instrument into a patient. Thus, thecatheter can be introduced into the working channel 200 at the proximalportion 130 and inserted through the entire body 110 of the sleevedevice 100 until it emerges from the distil tip portion 120.

In the embodiment depicted in FIG. 4, the sleeve device 100 contains asingle, round working channel 200. In alternate embodiments of thesleeve device 100, the working channel 200 need not be round or of thesize depicted. For example, the working channel 200 may have across-sectional shape in the form of a square or other polygon thatmates with the medical instrument to be passed therethrough. Also, theworking channel 200 need not be a single lumen. In alternateembodiments, the sleeve device 100 may include multiple workingchannels, such as adjacent channels or coaxial channels that permit theintroduction of multiple medical instruments (e.g., catheters,endoscopes, or the like). Furthermore, the multiple working channels maybe selectively sealable so that one working channel could be accessedwhile another is sealed. In such cases, it would be possible tointroduce and secure several catheters at different points in time.

Still referring to FIGS. 3-4, the actuator channel 210 of the sleevedevice 100 is formed in the body 110 and can movably receive an actuatorrod 220. The actuator channel 210 may be defined by one or more sidewalls 212 that can slidably engage the actuator rod 220. Movement of theactuator rod 220 within the actuator channel 210 can urge the anchors160 to extend from, or retract into, the actuator channel 210. In thisembodiment, the cross-sectional shape of the actuator rod 220 may bethat of a quadrilateral to permit longitudinal movement of the actuatorrod 220 while hindering the rotational movement of the actuator rod 220about its longitudinal axis. While this embodiment of the anchor sleeve100 contains an actuator channel 210, other embodiments may havenon-adjustable anchors or no anchors at all (refer, for example, toFIGS. 9-11) and as such may not include an actuator channel 210 orrelated components.

Referring now to FIG. 5, the actuator rod 220 of the sleeve device 100can be reciprocated within the actuator channel 210 in the longitudinaldirection of the sleeve device 100. The actuator rod 220 may include aproximal end 222 that is coupled to the actuator 170 via, for example, aconnector portion 171 of the actuator 170. As such, movement of theactuator 170 can be translated to the actuator rod 220. The actuator 170can be slidably engaged with the body 110 and may include acircumferential inner wall 172 that can slidably mate with acircumferential outer wall 114 of the body 110. When the actuator 170 ismoved relative to the body 110, the inner wall 172 and the outer wall114 may stay in contact such that a seal is maintained against thetransfer of liquids. The actuator rod 220 has a distal end 224 that canbe advanced and retracted within the actuator channel 210 in response tothe movement of the actuator 170. The anchors 160 can be coupled to theactuator rod 220 such that movement of the actuator 170 (and thecorresponding translation of the actuator rod 220 within the actuatorchannel 210) causes the anchors 160 to shift between the non-deployedposition and the deployed position. In this embodiment, the anchors 160are integrally formed with the actuator rod 220 (e.g., formed from anitinol material or the like).

The actuator channel 210 may not extend fully through the body 110 ofthe anchor sleeve 100. For example, the actuator channel 210 may extendfrom the proximal portion 130 to a depth that extends to a terminal end214. In some embodiments, when the actuator 170 is pressed against thestopper 180, the anchor actuator rod 220 is caused to advance within theanchor actuator channel 210 such that the distal end 224 of the actuatorrod 220 approaches the terminal end 214 of the actuator channel 210. Inthis embodiment, the anchors 160 are coupled to the actuator rod 220 sothat the anchors 160 retract into the body 110 as the distal end 224 ofthe rod 220 approaches the terminal end 214 (shifts to the non-deployedstate). In such circumstances, the anchors 160 may be flexed to astressed condition while retained within the actuator channel 210.

It should be understood from the description herein that, in someembodiments, the anchors 160 can be joined with the actuation rod 220 ata location other than the distal end 224. For example, in otherembodiments, the anchors 160 may be connected to the actuator rod 220along a middle region of the rod 220. Also, in alternative embodiments,the anchors 160 may be non-integral with the actuator rod 220. Forexample, the anchors may be formed separately from the actuator rod 220and then mounted to the rod 220 using an adhesive, a weld, a connector,or the like.

As shown in FIG. 5, the actuator 170 can be pulled back from the stopper180, and this movement is translated to the actuator rod 220 via theconnector portion 171. The actuator rod 220 slides within the actuatorchannel 210 so that the distal end 224 of the rod shifts away from theterminal 214. This motion of the actuator rod 220 causes the distal tips161 of the anchors 160 to pass through the openings 112 and therebyextend outwardly from the body 110. It should be understood from thedescription herein that, in alternative embodiments, the actuator rod220 and anchors 160 could be configured so that pulling the actuator 170in the direction away from the stopper 180 would cause the anchors 160to transition to their non-deployed state, while pressing the actuator170 in the direction of the stopper 180 would cause the anchors 180 totransition to the deployed state.

Referring now to FIG. 6A, the working channel 200 can extend through thelength of the sleeve device 100 and can receive at least one catheter orother medical instrument. In some embodiments, the working channel 200can have a diameter of about 3 French to about 30 French, and about 5French to about 20 French, including particular ranges from about 3French to about 7 French and about 12 French to about 17 French. Assuch, the working channel 200 can accept a wide range of catheters andmedical instruments. The working channel 200 can extend from a proximalopening 202 located in the proximal portion 130 of the sleeve 100 to adistal opening 204 located in the distil tip portion 120 of the sleeve100. When a catheter or other medical instrument is inserted into thesleeve device 100, it enters the working channel 200 via the proximalopening 202, travels through an opening 116 in the body 110, continuesto travel down the working channel 200 until emerging from the distalopening 204.

In some embodiments, the actuator 170 is slidably engaged with the body110 such that the actuator 170 may move longitudinally relative to thestopper 180. The sleeve device 100 may include a locking device 174 thatcan be adjusted to clamp to, or otherwise connect with, the catheterpassing through the working channel 200. As such, the locking device 174serves as a mechanism that releasably secures the catheter to the sleevedevice 100 after the catheter has been advanced through the sleevedevice 100 toward a targeted location. In some circumstances, thelocking device 174 can also form a seal around the catheter whenconnected thereto. As described in more detail below in connection withFIG. 6B, locking device 174 can include one or more components thatextend from the proximal face 118 of the sleeve body 110. In addition,the locking device 174 may also include side walls 178 which slidablyengage an inner walls 179 of the actuator 170, thus creating a dynamicseal as the actuator 170 moves longitudinally relative to the body 110.

Referring now to FIG. 6B, some embodiments of the locking device 174 mayinclude first and second jaws 175 a-b that operate to clamp upon theouter surface of the catheter when the catheter is position in theworking channel 200. (It should be understood that the catheter and theactuation rod 220 have been removed from view in FIG. 6B for purposes ofillustrating the locking device 174). For example, the first and secondjaws 175 a-b can compress the catheter into a locking engagement inresponse to movement of the actuator 170. As such, the catheter can beadvanced through the working channel 200 to a targeted location insidethe patient's body. Thereafter, the actuator 170 can be shifted awayfrom the stopper 180 so as to deploy the anchors 160 (as previouslydescribed in connection with FIG. 5). This movement of the actuator 170can also cause the second jaw 175 b to shift relative to the first jaw175 a so as to compress the outer surface of the catheter (or othermedical instrument) disposed in the working channel 200.

In this embodiment, the first jaw 175 a is a fixed component thatextends from the proximal surface 118 of the sleeve body 100. Forexample, the first jaw 175 a may be integrally formed with the sleevebody 100. The second jaw 175 b is adjustable relative to the first jaw175 a so as to provide a clamping action or other locking operation. Forexample, the second jaw 175 b can extend from the proximal surface 118so as to be cantilevered from the sleeve body 110. The second jaw 175 bmay include at least one cam surface 176 a that slidably engages a guidemember 177 of the actuator 170. The cam surface 176 a can include adecline path or other configuration that causes the guide member 177 toforce the second jaw 175 b toward the first jaw when the actuator 170(and the guide member 177) are moved away from the stopper 180. Thus,the motion of the actuator 170 causes the guide member 177 to act uponthe cam surface 176 a and shift the second jaw 175 b toward the firstjaw 175 a, thereby causing the jaws 175 a-b to clamp or otherwise lockonto the medical instrument inside the working channel 200.

It should be understood that, in some embodiments, the locking device174 may include one or more seal members arranged between the opposingsurfaces of the jaws 175 a-b. For example, a silicone seal having ahalf-cylinder shape can be affixed to the inner cylindrical face of thefirst jaw 175 a, and an opposing silicone seal having a half-cylindershape can be affixed to the inner cylindrical face of the second jaw 175b. As such, when the second jaw 175 b is forced toward the first jaw 175a, the opposing seal members would surround and compress the outersurface of the catheter arranged in the working channel 200. In suchembodiments, the locking device 174 can form a seal around the catheterin addition to locking the catheter to the sleeve device 100.

Still referring to FIG. 6B, the guide member 177 may be stopped at theend of its travel by a notch 176 b formed in the second jaw 175 b. Thenotch 176 b can be configured to mate with the guide member 177 so thatfurther longitudinal movement of the guide member 177 (and the actuator170) is inhibited. In this embodiment, notch 176 b releases the guidemember 177 when the actuator 170 is moved in a return path toward thestopper 180. In such circumstances, the guide member 177 moves along thecam surface 176 a so that the second jaw 175 b can pivot away from thefirst jaw 174 a, thereby releasing the catheter from the lockingengagement with the sleeve device 100.

Referring now to FIG. 7, in some embodiments, the sleeve device 100 maybe inserted through a hole in skin 10 of a patient until at least aportion of the body 110 is located in a subcutaneous region 20. Inpreparation for insertion, the actuator 170 may be pressed against thestopper 180 to retract the anchors 160 through the anchor holes 112 andinto the non-deployed position inside the body 110. In particularembodiments, the sleeve device 100 can be introduced through a patient'sskin prior to commencement of a medical procedure or other treatment.For example, the sleeve device 100 may penetrate the skin 10 andsubcutaneous region 20 through a small incision made by a physician. Insome cases a dilation instrument may be used to assist in advancing thesleeve device 100 through the incision.

In some embodiments, once the sleeve device 100 has been insertedthrough the skin 10, at least a portion of the body 110 may be locatedinside the subcutaneous region 20. In this example, the sleeve device100 is inserted such that, for example, the distal tip portion 120, thecuff 140, and the anchor holes 112 are located inside the subcutaneousregion 20. In particular, the anchors holes 112 can be positioned in thesubcutaneous region 20 proximate to the underside of the skin 10. Assuch, the actuator 170, the stopper 180, and the proximal opening 202remain external to the skin so that a practitioner has access to theproximal opening 202 (e.g., to insert the catheter) and the actuator 170(e.g., to shift the anchors 160). The sleeve device 100 can bepositioned such that the distal opening 204 is adjacent to a targetedblood vessel 30 or other body lumen that will receive the catheter orother medical instrument passing through the sleeve 100.

Referring to FIG. 8, after the sleeve device 100 has been placed suchthat at least a portion of the body 110 (e.g., the distal tip portion120, the cuff 140, and the anchor holes 112) is in the subcutaneousregion 20, the sleeve device 100 can be anchored at least temporarilythrough the use of the deployed anchors 160. To deploy the anchors 160,the actuator 170 can be shifted in a proximal direction away from thestopper 180. In doing so, the anchors 160 are transitioned from thenon-deployed position inside the body 110 to the deployed positionoutside of the body 110 by extending out of the anchor holes 112. As theanchors 160 extend through the anchor holes 112, they transition fromtheir stressed shape inside the body 110 to their memory shape (e.g.,curved shape in this example). When the anchors 160 extend from theanchor holes 112, which are positioned just under the skin 10 in thesubcutaneous region 20, the curved shape of the anchors 160 can allowthem to deploy adjacent to the skin 10 without tearing or otherwisedamaging it. When deployed, the anchors 160 can exert a retainment forceon the body 110 that secures the position of the sleeve device 100relative to the skin entry point. In some embodiments, the anchors 160may provide a holding force of about 1 lb. or greater, depending uponthe medical procedure being performed, the materials comprising theanchors 160, the geometry of the anchors 160, and/or other factors. Forexample, the anchors 160 may provide a holding force of about 0.5 lbs ormore, about 1 lb to about 20 lbs, about 1 lb to about 5 lbs, or about 2lbs to about 3 lbs.

In some embodiments, while the anchors 160 are serving as a temporary orlong-term device for retaining the sleeve device 100, some bodily tissuecan grow into or otherwise embed with the cuff 140 over a period oftime. When embedded with the surrounding bodily tissue, the cuff 140 canserve as a long-term anchor for the sleeve device 100, either in lieu ofthe anchors 160 or as a supplement to the anchors 160. Furthermore, thecuff 140 can act as a barrier against infection, for example, byminimizing the transmittance of bacteria from the external surface ofthe skin 10 to underlying anatomical structures, such as the bloodvessel 30. In some embodiments, after a period of time has elapsed whichis long enough for tissue to have grown into the cuff 140, the anchors160 may be transitioned back to their non-deployed position, thus nolonger utilizing the anchors 160 to secure the sleeve device 100 inplace. Alternatively, the anchors 160 may be left in their deployedposition to act as an additional long-term anchor point for the sleevedevice 100.

Still referring to FIG. 8, the sleeve device 100 can be operated as partof a system including the sleeve device 100 and another medicalinstrument. When the sleeve device 100 has been inserted in thesubcutaneous region 20 and has been anchored there (e.g., by the anchors160, the cuff 140, or a combination thereof), a medical instrument, suchas a catheter 300, can be introduced through the working channel 200(FIGS. 4 and 6) and into the body. For example, the catheter 300 can beinserted into the working channel 200 of the sleeve device 100 at theproximal opening 202, and can continue to be advanced until it emergesfrom the distal opening 204 along the distal tip portion 120. In theexample depicted in FIG. 8, the catheter 300 can continue to be advancedtoward a penetration location into a targeted blood vessel 30. As thesleeve device 100 and cuff 140 remain in place relative to the patient,the catheter 300 can be advanced until the catheter tip 302 reaches atargeted site within the body. Accordingly, the distance between thecuff 140 and the catheter tip 302 (e.g., the tip-to-cuff distance 310)can be selectively adjusted depending on the patient's size, thepatient's anatomy, the intended medical treatment, and other factors.

Advantageously, because the position of the catheter tip 302 isadjustable relative to the position of the sleeve device 100, thetip-to-cuff distance 310 can be selected by the practitioner while thecatheter tip 302 is advanced through the patient's body. Also, thetip-to-cuff distance 310 is adjustable at the time of insertion, so thisdistance need not be determined prior to the start of the procedure.Furthermore, such a system 5 that provides the adjustable tip-to-cuffdistance 310 can reduce the need for hospitals or clinics to inventory awide assortment of cuff-attached catheters, each having a non-adjustabletip-to-cuff length. Moreover, due to the adjustable nature of thetip-to-cuff distance 310, the practitioner is not required to trim thedistal portion of a catheter to achieve the desired dimensions, therebyby reducing the risk of over-shortening the catheter or alteringfeatures of the catheter tip.

Referring to FIG. 9, some alternative embodiments the sleeve device 400may include anchors 190 that do not retract into openings in theelongate body. For example, the anchors 190 may be designed to flex to aposition against the side of the elongate body 110′ during insertionthrough the skin and then to elastically return to a deployed position(e.g., a curved shape in this example) after entering into thesubcutaneous region. In the depicted embodiment, the sleeve device 400includes two flexible, non-retractable anchors 190 that comprise abio-compatible polymer material capable of elastically flexing duringinsertion into the subcutaneous region and capable of elasticallyflexing or plastically deforming during removal from the patient's skin.Similar to previously described embodiments, the anchors 190 can amaterial that exhibits superelasticity (e.g., Nitinol or the like). Theanchors 190 can be deployed in the subcutaneous region so as to at leasttemporarily retain the anchor sleeve 400 in engagement with thepatient's body while the cuff device embeds with the surrounding tissueover a period of time. In some embodiments, the anchors 190 may havegrooves or notches formed therein to facilitate the proper flexing ordeformation during insertion into the subcutaneous region or removalfrom the patient's skin, as described in more detail below. In theseexamples, the anchors 190 are not adjusted by an actuator, so the sleevedevice 400 may not include, for example, an actuator channel 210, anactivation rod 220, or an actuator 170 (as previously described inconnection with FIG. 5). In these embodiments, the sleeve device 400 caninclude one or more working channels 200 to receive a number of medicalinstruments. Furthermore, the sleeve device 400 may include a stationaryhandle 192 to assist in the insertion and removal of the sleeve device400 from a patient.

In some embodiments, the anchors 190 may extend away from the plane ofthe outer wall 114′ of the body 110′. As shown in FIG. 9, someembodiments of the body 110′ may comprise one or more wall pockets 124to receive the anchors 190 in the event they are flexed to anon-deployed position against the body 110′ (e.g., during insertion orextraction from a patient). In these embodiments, the wall pocket 124may serve to reduce the likelihood of trauma to the patient's skinduring insertion by providing a space to accommodate one or more of theanchors 190. When the sleeve device 400 is inserted into a patient, theanchors 190 may flex into a proximal region of the wall pocket 124 asthey pass through the entry hole in the skin. Once the sleeve device 400is inserted such that at least a portion of the body 110 (e.g.,including the distal tip portion 120 and the cuff 140) and the anchors190 are located in the subcutaneous region 20, the sleeve device 400 isin position such that the anchors 190 may return a deployed positionsimilar to that shown in FIG. 9. When the sleeve device 400 is removedfrom a patient, the anchors 190 are configured to elastically flex orplastically deform into a distal region of the wall pocket 124 as theyexit from the hole in the skin.

Still referring to FIG. 9, the sleeve device 400 can include a number offeatures that are similar to the previously described embodiments. Forexample, the sleeve device 400 can include the cuff 140 and the depthindicator 150 arranged on the elongate body 110′. The sleeve device 400may also include one or more working channels 200. In somecircumstances, the sleeve device 400 may include the working channel 200as described in connection with FIGS. 6A-B and other related features(e.g., the distal opening 204) so as to receive a medical instrumentsuch as a catheter 300.

Referring now to FIGS. 9-10, the sleeve device 400 may be introducedinto a patient so that the anchors 190 may releasably secure at least aportion of the body 110 in the subcutaneous region 20 of a patient. Theinsertion force applied to the body 110′ may cause at least a portion ofthe anchors 190 to flex during insertion through the skin entry point.For example, each anchor 190 may superelastically flex toward a proximalregion of the pocket 124 during insertion, and then can return to thedeployed position (e.g., having a curved shape in this embodiment) whenarranged in the subcutaneous region 20. In the event the sleeve device400 is to be removed from the subcutaneous region 20, the removal forceapplied to the body 110′ may cause at least a portion of the anchors 190to flex or deform toward a distal region of the wall pockets 124. Thus,the anchors 190 may be self-actuated without the need for a separateactuation device (e.g., the actuator rod 220, or the like) to extend orretract the anchors 190.

In some embodiments, the sleeve device 400 may be introduced through apatient's skin prior to commencement of a medical procedure or othertreatment. For example, the sleeve device 400 may be advanced throughthe skin 10 and into the subcutaneous region 20 via a small incisionmade by a physician. In some cases a dilation instrument may be used toassist in advancing the sleeve device 400. As a result of an insertionforce applied to the sleeve device 400 by the physician, the anchors 190may be temporarily flexed from their unstressed configuration (as shown,for example, in FIG. 9) to a proximally oriented configuration in whichthe anchors 190 extend substantially in a direction along the wallpockets 124 of the body 110′. Such flexing action permits at least aportion of the anchors 190 to enter through the incision with a reducedlikelihood of traumatizing the skin around the incision.

As shown in FIG. 10, after the anchors 190 have passed through the skin10, the anchors 190 can return partially or fully toward the unstressedconfiguration (as shown, for example, in FIG. 9) so as to deploy withinthe subcutaneous region 20. For example, the subcutaneous region 20 maycomprise fatty tissue in which the anchors 190 can move in a sweepingarcuate motion away from the body 110′. Such deployment in thesubcutaneous region 20 can releasably secure the sleeve device 400 tothe patient's body for a period of time while the cuff 140 embeds withthe surrounding tissue (as previously described). In this embodiment,the anchors 190 extend away from the outer wall 114′ of the body 110′with a curvature so that the tips of the anchors 190 are not necessarilypointed at the underside of the skin 10. Such a configuration may beaccomplished, for example, by inserting the anchors 190 further into thesubcutaneous region 20 and then moving the anchors 190 with a slightpulling motion to permit the anchors 190 to sweep outwardly from thebody 110′. It should be understood that, due to the vagaries of humananatomy and differing inward and outward forces during treatment, insome embodiments the orientation and position of the deployed anchors190 may vary when deployed in the subcutaneous region 20. In someembodiments, the anchors 190 may provide a holding force of about 1 lb.or greater, depending upon the medical procedure being performed, thematerials comprising the anchors 190, the geometry of the anchors 190,and/or other factors. For example, the anchors 190 may provide a holdingforce of about 0.5 lbs or more, about 1 lb to about 20 lbs, about 1 lbto about 5 lbs, or about 2 lbs to about 3 lbs.

In some embodiments, once the sleeve device 400 has been insertedthrough the skin 10, at least a portion of the body 110 may be locatedinside the subcutaneous region 20. In this example, the sleeve device400 is inserted such that, for example, the distal tip portion 120, thecuff 140, and the anchors 190 are located inside the subcutaneous region20, and the handle 192 remains external to the patient. Similar topreviously described embodiments, the sleeve device 400 can bepositioned such that the distal opening 204 is near to a blood vessel 30and the proximal opening 202 is external to the patient so as to receivea catheter 300 (FIG. 8) or other medical instrument. As previouslydescribed in connection with FIG. 8, the distance between the cuff 140and the catheter tip can be selectively adjusted depending on thepatient's size, the patient's anatomy, the intended medical treatment,and other factors.

Still referring to FIG. 10, the sleeve device 400 may be removed byapplying a removal force applied to the sleeve device 400 that overcomesthe retainment force. In such circumstances, the anchors 190 may beflexed or deformed from their deployed configuration (as shown, forexample, in FIG. 9) to a distally oriented configuration in which theanchors 190 extend substantially in a direction along the wall pockets124 of the body 110. Such flexing action permits at least a portion ofthe anchors 190 to exit through the incision in the patient's skin witha reduced likelihood of traumatizing the skin around the incision. Forexample, the anchors 190 may have a curved configuration in which thetips do not point directly at the skin 10) when deployed in thesubcutaneous region 20. As such, the removal force causes the anchors190 to flex or deform (rather than substantially tear through theunderside of the skin 10) in a generally sweeping motion toward thedistally oriented configuration. In the embodiments in which the anchors190 comprise a nitinol material exhibiting superelastic characteristics,the anchors 190 can return toward the unstressed configuration (asshown, for example in FIG. 10) following removal of the sleeve device100 from the skin. In some alternative embodiments, the anchors 190 maycomprise a biocompatible polymer material that can be elastically orplastically deformed into the distally oriented configuration as aresult of the removal force applied to the sleeve device 100.

Referring to FIG. 11, some alternative embodiments of the sleeve device410 may not include anchors 160 or 190. For example, the sleeve device410 may be inserted through a hole in the patient's skin (as previouslydescribed) to a targeted position within the subcutaneous region 20. Insuch circumstances, the distal tip portion 120 and the cuff 140 can belocated in the subcutaneous region, while the handle 192 remainsexternal to the patient. The sleeve device 410 can be positioned suchthat the distil opening 204 is near to a blood vessel and the proximalopening 202 is external to the patient such that it can accept acatheter 300″ or other medical instrument. Once in position, the sleevedevice 410 may receive a temporary retainer (e.g., medical tape,stitches, or the like) to maintain the sleeve device 100 in a desiredposition for a period of time until the cuff 140 embeds with thesurrounding tissue (as previously described) to thereby create along-term anchor. In addition, the cuff 140 can provide a barrier toinfection, as previously described.

In some embodiments, after placement of the sleeve 410 in a patient, adual lumen catheter 300″ with a staggered tip 304″ can be introducedinto the working channel 200 of the sleeve device 410. For example, thecatheter 300″ can be inserted into the proximal opening 202, and cancontinue to be advanced until it emerges from the distil tip portion120. As with previously described embodiments, the tip-to-cuff distance310 between the cuff 140 and the catheter tip 304″ can be selectivelyadjusted by a practitioner while the catheter tip 304 is advanced in thepatient's body.

Referring to FIG. 12, some alternative embodiments of the sleeve device420 may employ the anchors 160 without the subcutaneous cuff device 140arranged on the sleeve body 110. In such circumstances, the anchorsleeve device 420 may include the actuator 170 that adjust the anchors160 from a non-deployed position (e.g., retracted inside the sleeve body110) to the deployed position inside the subcutaneous region 20. Aspreviously described in connection with FIG. 6B, the sleeve device 420may include a locking device 174 that is shifted when the actuator 170is moved to deploy the anchors 160. Although the subcutaneous cuffdevice 140 is not included on the body 110 in this particularembodiment, the anchors 160 can be deployed into the subcutaneous regionto retain the sleeve device 420 to the patient's body while the catheteror other medical instrument is passed through the working channel 200and into the targeted site in the patient's body. Thus, the user canreadily operate the actuator 170 is a single motion thatcontemporaneously deploys the anchors 160 in the subcutaneous region andlocks the sleeve body 110 to the catheter or other medical instrument.Furthermore, as previously described in connection with FIG. 6B, thelocking device 174 can also form a seal around the catheter whencompressed thereon. In such circumstances, the motion of the actuator170 can cause the anchors 160 to deploy in the subcutaneous region andalso cause the sleeve body 110 to lock with and seal around the catheterthat resides in the working channel 200.

Referring now to FIGS. 13-14, particular embodiments of the sleevedevice 100 may be particularly suited for use providing chronic dialysistreatment. For example, the sleeve device 100 (shown here as theembodiment described in connection with FIGS. 1-8) can be used as partof a system 6 for the placement of a dialysis catheter 320, which may beused to provide long-term hemodialysis treatment. In some patientsrequiring long-term hemodialysis, a dialysis catheter tip 322 can bepositioned in the superior vena cava or right atrium to provide theinlet and outlet of the extracorporeal circuit. As such, the cuff 140 ofthe sleeve device 100 can embed with the tissue in the subcutaneousregion near the skin entry point so as to provide a barrier toinfection. Because the path from the skin entry point (e.g., in theupper torso near the clavicle) to the targeted heart chamber 60 is notidentical for all patient's, the system 6 advantageously permits thetip-to-cuff distance (e.g., the distance between the catheter tip 322and the cuff 140) to be selectively adjusted by the practitioner duringuse.

In this example, a small incision 40 can be made in the upper torso(e.g., near the clavicle) through which the sleeve device 100 may beinserted and secured in the subcutaneous region as previously described.Similar to the embodiments described in connection with FIGS. 7-8, thesleeve device 100 may penetrate through the small incision andthereafter be advanced with the assistance of a dilation instrument.Once the sleeve device 100 has been inserted through the skin 10, atleast a portion of the body 110 is located inside the subcutaneousregion 20. In this example, the sleeve device 100 is inserted such thatthe distal tip portion 120, the cuff 140, and the anchor holes 112 arelocated inside the subcutaneous region 20 under the skin, and theactuator 170 and the stopper 180 remain external to the patient. Thesleeve device 100 can be positioned such that the distal opening 204 isdirected toward the jugular vein and the proximal opening 202 isexternal to the patient such that it can subsequently accept thecatheter 320 or other medical instrument. Once the sleeve device 100 hasbeen introduced, it can be anchored at least temporarily through the useof the deployed anchors 160. To deploy the anchors 160, the actuator 170can be pulled back away from the stopper 180 (as previously described inconnection with FIG. 8).

Still referring to FIG. 13, after the sleeve device 100 is at leasttemporarily secured in the subcutaneous region, the dialysis catheter320 can be introduced through the working channel 200 (FIG. 8) of thesleeve device 100 and then directed toward the targeted heart chamber60. In one example, the sleeve device 100 can inserted into thesubcutaneous layer through a skin insertion point in the chest near theclavicle. The dialysis catheter 320 can be advanced through the workingchannel 200 of the sleeve and into the subcutaneous region where itpasses through a subcutaneous tunnel toward the jugular vein. An accessneedle (not shown in FIG. 13) can be used to create a venous entry 50into the jugular vein approximately one to two centimeters above theclavicle. For instance, the Seldinger technique may be used to accessthe jugular vein followed by placement of a peel-away sheath.Thereafter, the tip portion 322 of the dialysis catheter 320 is advancedthrough the peel-away sheath at the venous entry point 50 and isdirected into the targeted heart chamber 60 (e.g., the right atrium inthis example) via the superior vena cava using, for example, ultrasoundimaging or fluoroscopy guidance. The dialysis catheter 320 may includeone or more markers along the catheter body to provide visualizationusing the medical imaging system. The peel-away sheath can be promptlyremoved and any skin opening in the neck (e.g., temporary skin openingfor insertion of peel-away sheath) can be closed. The anchor sleevedevice 100 can be secured in position on the patient's chest so as toprovide long-term access for the dialysis catheter 320.

As previously described in connection with FIG. 8, the cuff 140 of thesleeve device 100 can embed with the surrounding tissue in thesubcutaneous region so as to serve as a barrier to infection and toserve as a long-term anchor of the sleeve device 100. The anchors 160can be deployed for a period of time so as to retain the sleeve device100 in place while the cuff 140 receives the tissue ingrowth. When thecuff 140 is embedded with the tissue, the anchors 160 can betransitioned to the non-deployed position inside the body 110 by pushingthe actuator 170 in the direction of the stopper 180. Alternatively, theanchors 160 can be left in their deployed position in the subcutaneouslayer 20 for the purpose of functioning as a supplemental anchoringfeature.

Still referring to FIG. 13, catheter tip 322 can be advanced toward thetargeted heart chamber 60 while the sleeve device 100 and cuff 140remain generally stationary relative to the skin entry point.Accordingly, the distance between the cuff 140 and the catheter tip 322(e.g., the tip-to-cuff distance) can be selectively adjusted dependingon the patient's size, the patient's anatomy, the intended medicaltreatment, and other factors. As previously described, the tip-to-cuffdistance can be advantageously selected by the practitioner while thecatheter tip 322 is advanced through the patient's body. Also, thetip-to-cuff distance is adjustable at the time of insertion, so thisdistance need not be determined prior to the start of the procedure.Furthermore, this system 6 having the adjustable tip-to-cuff distancecan reduce the need for hospitals or clinics to inventory a wideassortment of cuff-attached catheters, each having a non-adjustabletip-to-cuff length.

Referring now to FIG. 14, the dual lumen tip 322 of the dialysiscatheter 320 can be arranged the right atrium 60 of the heart. After thefinal position of the tip 322 is verified using a medical imagingsystem, the dialysis catheter 320 can be used to perform the dialysistreatment. For example, the dialysis catheter 320 may include duallumens that extend to distal ports at the staggered tip 322. In oneembodiment, the staggered ports at the tip 322 may be separated by adistance of approximately one or two centimeters. The staggered positionof these ports may facilitate the dialysis procedure. For example, afirst port in the catheter tip 322 may be used to suction blood from theheart chamber 60 and into the extracorporeal circuit (not shown in FIGS.13-14), and a second opening in the catheter tip 322 can be used toreturn the blood into the heart chamber. It should be understood that,in some embodiments, the sleeve device 100, 400, 410, or 420 describedherein can be used with other medical instruments and can be used fortreatments other than dialysis. For example, the sleeve device 100, 400,410, or 420 can be used in combination with one or more Hickmancatheters for delivery of chemotherapy treatment. The Hickman cathetersmay comprise single-lumen, double-lumen, or triple-lumen elongate bodiesthan can pass through one or more working channels of the sleeve device100, 400, 410, or 420. In another example, the sleeve device 100, 400,410, or 420 can be used in combination with at least one tunnel chesttube that is used to drain fluids from the lung cavity of the patient.In such circumstances, the sleeve device 100, 400, 410, or 420 can beretained in the subcutaneous region while the tunnel chest tubepenetrates into the lung cavity (e.g., not necessarily into an artery orvein or the patient).

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. A method of delivering a catheter device to an internal body site, comprising: advancing flexible anchors of a catheter anchor device through a percutaneous opening in a skin layer so that the flexible anchors and a subcutaneous cuff device of the catheter anchor device are disposed in a subcutaneous region along an underside of the skin layer, the subcutaneous cuff device comprising a biocompatible material that is configure to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer; moving a catheter through the percutaneous opening in the skin layer toward a targeted body site such that a distal tip of the catheter is moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer, wherein a distal length of the catheter extending distally from a distal end of the catheter anchor device is greater than a maximum length of the catheter anchor device, wherein the distance from the subcutaneous cuff device to the distal catheter tip defines a cuff-to-tip distance, wherein said moving causes adjustment of the cuff-to-tip distance while the subcutaneous cuff device is disposed in the subcutaneous region along the underside of the skin layer; and releasably securing the catheter to the catheter anchor device after the adjustment of the cuff-to-tip distance.
 2. The method of claim 1, wherein the distal end of the catheter anchor device resides external to a venous entry point of a blood vessel that is occupied by the catheter after the distal tip of the catheter is advanced to the targeted body site.
 3. The method of claim 1, wherein the flexible anchors are adjustable from a non-deployed orientation to a deployed orientation in the subcutaneous region along the underside of the skin layer.
 4. The method of claim 1, wherein the catheter anchor device comprises a sleeve body.
 5. The method of claim 4, wherein the sleeve body comprises a lumen configured to receive the catheter.
 6. A method of delivering a catheter device to an internal body site, comprising: advancing flexible anchors of a catheter anchor device through a percutaneous opening in a skin layer so that the flexible anchors and a subcutaneous cuff device of the catheter anchor device are disposed in a subcutaneous region along an underside of the skin layer, the subcutaneous cuff device comprising a biocompatible material that is configure to receive tissue ingrowth when disposed in the subcutaneous region along the underside of the skin layer; moving a catheter through the percutaneous opening in the skin layer toward a targeted body site such that a distal tip of the catheter is moved relative to the subcutaneous cuff device disposed in the subcutaneous region along the underside of the skin layer, wherein the catheter anchor device comprises a gripper portion that is adjustable to frictionally engage at least a portion of an outer circumferential surface of the catheter, wherein the distance from the subcutaneous cuff device to the distal catheter tip defines a cuff-to-tip distance, wherein said moving causes adjustment the cuff-to-tip distance while the subcutaneous cuff device is disposed in the subcutaneous region along the underside of the skin layer; and releasably securing the catheter to the catheter anchor device by adjusting the gripper portion of to releasably compress against said portion of the outer circumferential surface of the catheter, wherein at least a portion of the catheter anchor device is configured to adjust from a first position to a second position so as to simultaneously shift the flexible anchors to a deployed orientation and to shift the gripper portion to compress the outer surface of the catheter device.
 7. The method of claim 1, wherein the catheter defines at least two lumens that extend to the distal tip of the catheter, and wherein a total axial length of the catheter is greater than a total axial length of the catheter anchor device.
 8. The method of claim 1, wherein at least a proximal portion of the catheter anchor device resides external to the percutaneous opening in the skin layer while the flexible anchors and the subcutaneous cuff device are disposed in the subcutaneous region along the underside of the skin layer.
 9. The method of claim 1, wherein the subcutaneous cuff device inhibits migration of infection when the cuff device is embedded in the subcutaneous region along the underside of the skin layer.
 10. The method of claim 9, wherein the subcutaneous cuff device receives the ingrowth of bodily tissue over a period of time so as to inhibit the migration of infection from outside the skin and into the blood stream.
 11. A catheter anchor device for securing a position of a catheter relative to a percutaneous opening in a skin layer occupied by the catheter, comprising: a catheter engagement body having a gripper portion that is adjustable to frictionally engage at least a portion of an outer circumferential surface of a catheter when a catheter is inserted into a percutaneous opening in a skin layer; a subcutaneous anchor mechanism coupled to the catheter engagement body, the subcutaneous anchor mechanism having first and second flexible anchors that are adjustable from a first position to a second position in which a free end of the first flexible anchor extends generally oppositely away from a free end of the second flexible anchor, wherein the first and second flexible anchors are configured to abut tissue in a subcutaneous region along an underside of the skin layer; a subcutaneous cuff device coupled to the catheter engagement body, the subcutaneous cuff device comprising a biocompatible material to receive ingrowth of bodily tissue when disposed in the subcutaneous region, wherein the subcutaneous cuff device is positioned relative to the gripper portion of the catheter engagement body such that, when the catheter is moved through the percutaneous opening in the skin layer, a cuff-to-tip distance between the subcutaneous cuff device and a distal tip of the catheter is manually selectable; and wherein the catheter engagement body is configured to releasably secure to the catheter by shifting the gripper portion of to releasably compress against said portion of the outer circumferential surface of the catheter after each of the catheter and the flexible anchors is inserted through the percutaneous opening in the skin layer, wherein at least a portion of the catheter engagement body is configured to adjust from a first position to a second position so as to simultaneously shift the flexible anchors to the second position and to shift the gripper portion to compress the outer surface of the catheter device.
 12. The method of claim 6, wherein at least a proximal portion of the catheter anchor device resides external to the percutaneous opening in the skin layer while the flexible anchors and the subcutaneous cuff device are disposed in the subcutaneous region along the underside of the skin layer, and wherein the subcutaneous cuff device receives the ingrowth of bodily tissue over a period of time so as to inhibit the migration of infection from outside the skin and into the blood stream.
 13. The device of claim 11, wherein the subcutaneous cuff device is coupled to the catheter engagement body at a position such that the subcutaneous cuff device is configured to reside in the subcutaneous region along the underside of the skin layer while at least a proximal portion of the catheter engagement body resides external to the skin layer, and wherein the subcutaneous cuff device is configured to receive the ingrowth of bodily tissue over a period of time so as to inhibit the migration of infection from outside the skin and into the blood stream. 